Assessment of Right Ventricular Volume in Tetralogy of Fallott (TOF) Patients

Tetralogy of Fallot Clinical Trial

— VMS TOF  

Official title:

Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Tetralogy of Fallott Following Repair; A Comparison Study to cMRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419756
• Other study ID #: 2011041
• Status: Completed
• Phase: N/A
• First received: August 16, 2011
• Last updated: October 3, 2014
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: July 2013
• Source: VentriPoint Diagnostics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Assessment of Right Ventricular Volume using the VentriPoint Medical system in patients with Tetralogy of Fallot following repair; a comparison study to cMRI.

The objective of this study is: To evaluate the accuracy of the VentriPoint Medical System to calculate right ventricular volumes in patients with Tetralogy of Fallot following surgical repair.

Secondary objectives are: To validate Inter and Intra observer variability at 3 clinical sites.

The analyses will be the same for EDV and ESV. For either right ventricular volume, the primary effectiveness measure is the % difference between VMS and cMRI results, i.e. (VMS-cMRI)*100%/average of VMS and cMRI results. There will be two null hypotheses for the primary analysis:

H0+: true mean % difference > 10% and H0-: true mean % difference < -10%

The observed mean % difference will be presented with 95% confidence intervals. The VMS right ventricular volume estimates will be regarded as equivalent to cMRI estimates if both H0+ and H0- are rejected at a 1-sided 0.025 level by a paired t test for both EDV and ESV. Since H0+ and H0- cannot both be true, the total type I error rate for each measure is 0.025 and the overall type I error rate for both EDV and ESV is 0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with Tetralogy of Fallot following surgical repair

• Patients who can be expected to lie motionless during imaging

Exclusion Criteria:

• Lack of informed consent

• Surgical repair for Tetralogy of Fallot with RV-PA conduit

• Known arrhythmia that interferes with image acquisition.

• Implanted cardiac defibrillator, pacemaker, or other devices containing ferromagnetic materials

• Pregnant woman

• Contraindications for MRI

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tetralogy of Fallot

Intervention

Device:
• VentriPoint Medical System
The Knowledge Based Reconstruction (KBR) method generates a 3D reconstruction of the RV based on the Piecwise smooth subdivision surface method but without requiring manual border tracing. Instead KBR reconstructs a new patient's ventricular surface from the placement of anatomic landmark points on a 2D ultrasound image

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Cleveland Clinic	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	The Children's Hosptial of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VentriPoint Diagnostics Ltd.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of this study is the percent difference between the VentriPoint Medical System (VMS) and cMRI for estimating the end diastolic and end systolic right ventricular volumes (EDV and ESV) in subjects following repair for TOF.	The trial will be regarded as successful if it demonstrates the mean VMS-cMRI percent difference to be <10% and >-10% at a 1-sided 0.025 statistical significance level for each of EDV and ESV, with no safety concerns for the VMS procedure.	4 months	No